Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition

NCT03146897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2691

Last updated 2019-04-18

No results posted yet for this study

Summary

The research seeks to determine the relative effectiveness and cost effectiveness of alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal program settings. The results of this study will guide decisions about what commodities to use in supplementary feeding programs in particular contexts and populations, and what factors need to be addressed to ensure maximum effectiveness in the treatment of moderate malnutrition.

Tufts University, Washington University in St. Louis, School of Medicine, Sierra Leone Ministry of Health and Sanitation (MoHS), Project Peanut Butter, Caritas Bo, World Food Programme (WFP), and the United States Agency for International Development (USAID) are collaborating to conduct an assessment of the effectiveness, cost, and cost-effectiveness of food aid commodities in treating moderate acute malnutrition (MAM) in young children. The study comparison is based on a targeted food delivery to children 6-59 months who are screened for MAM. Study participants will receive one of four approximately isoenergetic test foods:

1. Super Cereal Plus (SC+) with amylase
2. Corn-soy Blend Plus (CSB+) and fortified vegetable oil
3. Corn-soy Whey Blend (CSWB) and fortified vegetable oil (CSWB is a new product which is a modified version of CSB)
4. Ready-to-use Supplementary Food (RUSF, lipid-based)

Conditions

  • Moderate Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Supplementary Food

Supplementary food for treating MAM

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER
  • Project Peanut Butter

    collaborator OTHER
  • Caritas Bo

    collaborator UNKNOWN
  • Ministry of Health and Sanitation, Sierra Leone

    collaborator OTHER_GOV
  • United Nations World Food Programme (WFP)

    collaborator OTHER
  • United States Agency for International Development (USAID)

    collaborator FED
  • Tufts University

    lead OTHER

Principal Investigators

  • Beatrice Rogers, PhD · Tufts University

  • Mark Manary, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2018-11-24
Completion
2018-11-24

Countries

  • Sierra Leone

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03146897 on ClinicalTrials.gov